Drug Technical Advisory Board (DTAB) Recommends Amendments To The Medical Devices Rules, 2017 – Food, Drugs, Healthcare, Life Sciences

India:

Drug Technical Advisory Board (DTAB) Recommends Amendments To The Medical Devices Rules, 2017

The Medical Devices Rules (MDR), 2017, was published vide G.S.R.
78(E) dated January 31, 2017 under the provisions of Drugs and
Cosmetics Rules by the Ministry of Health and Family Welfare
(MoH&FW). The MDR, 2017, rules were made effective from January
01, 2018 to regulate the clinical investigation, manufacture,
import, and sale & distribution of Medical Devices in the
country.

On May 16, 2018, the 79th meeting of Drug Technical Advisory
Board (DTAB) considered the representations from the industry/
stakeholders/ associations for amending the MDR, 2017.The DTAB
deliberated the matter and recommended to amend the following
provisions of DMR, 2018¹:

The DTAB deliberated the matter and recommended the
environmental requirements for the final packing of sterile
surgical dressings and also for final packing of condoms. Annexure
A of 5th Schedule of DMR, 2017, may be amended as follows:

1. “Annexure A of the Fifth
   Schedule of said rules may be amended as follows:

   1. Environmental conditions for weaving
      and assembly and gauzing should be deleted and only final primary
      packing for sterile surgical dressings should be included,
      accordingly, for sterile surgical dressings, Annexure A should be
      amended and the provision should be substituted with following:
      

      

   
   

   2. Similarly, for condoms neat &
      clean environment free from dust etc. shall be replaced instead of
      5 μ filter.”

1. The Board (DTAB) deliberated the
   matter and agreed for the proposal to amend the provisions in Rule
   64, making it identical for waiver of clinical performance
   evaluation of In-vitro Diagnostic medical devices inline with
   waiver given for medical devices under Rule 63 of the Medical
   Device Rules, 2017.




2. The Board recommended that in case a
   medical device which already exists in the Indian market for use is
   brought in future under regulation, then such device shall not be a
   new medical device with condition that the applicant need to
   provide evidences of safety, performance & effectiveness.




3. The Board deliberated the matter and
   agreed for the proposal for enabling NABL accredited laboratories
   or any hospital accredited by national accreditation board for
   hospitals and health care providers (NABH) for issuing performance
   evaluation report under Medical Devices Rules, 2017, to harmonize
   the requirements at par with the international rules and
   accordingly, the requirements specified in sub-clause (h) of clause
   (ii) of Part II of the Fourth Schedule may be amended.




4. The Board deliberated the matter and
   agreed for the proposal to include the following medical devices
   and other high end equipments under the purview of Section 3(b)
   (iv) of the Drugs and Cosmetics Act, 1940:

   1. All implantable medical devices

   
   

   2. CT scan equipment

   
   

   3. MRI equipment

   
   

   4. Defibrillators

   
   

   5. Dialysis Machine

   
   

   6. PET equipment

   
   

   7. X-Ray Machine




5. The Board deliberated the matter and
   agreed for the proposal to incorporate pharmacy degree/
   post-graduation as a qualification in Medical Devices Rules,
   2017.




6. The Board deliberated the matter and
   agreed for the proposal to accept the eIFU (electronic Instructions
   for Use) as an option in place of traditional paper IFU
   (Instructions for Use).




7. The Board recommended the sale of
   Invitro Diagnostic products shall be undertaken by a valid, whole
   license holder to Hospitals, Pathology Laboratories, Blood Banks
   & other such institutions, based on requisition for such
   products, & the records of which shall be maintained. In case
   an In-vitro Diagnostic product is to be sold directly to the
   consumer, it shall be supplied through a valid license holder, for
   retail sale for such products.




8. The Board deliberated the matter and
   agreed for the proposal for notification of bone marrow cell
   separator as a medical device under Section 3(b) (iv) of the Drugs
   and Cosmetics Act, 1940.




9. The Board deliberated the matter and
   agreed for the proposal for inclusion of medical devices approved
   by Licensing Authority under Drugs & Cosmetics Rules, 1945, to
   bear CDSCO logo on its labels.




10. The Board deliberated the matter and
    agreed for the proposal for adding to the definition of medical
    device in clause (ii) of rule 2 and clause (ii) of rule 3(zb)
    listed currently as, “substances including mechanical
    contraceptives (condoms, intrauterine devices, tubal rings),
    disinfectants and insecticides notified under sub-clause (ii)”
    the following words and to read –
    

    “disinfectants that are used to pre-clean or decontaminate
    medical devices prior/after to patient use and substances including
    mechanical contraceptives (condoms, intrauterine devices, tubal
    rings), notified under subclause (ii)”.

Further, the Board also recommended for allied amendments in
preamble/scope in the rules.

About DTAB

The Drugs Technical Advisory Board is constituted by Central
Government under the Drug and Cosmetic Act, 1940, to advise the
Central Government and the State Governments on technical matters
arising out of the administration of this Act and to carry out the
other functions assigned to it by this Act.

Footnotes

1 http://www.cdsco.nic.in/writereaddata/Final%20Minutes%20for%2079th%20DTAB%20meeting%20held%20on%2016_05_2018(1).pdf

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